Celltrion Internalizes SC Formulation Development Capabilities... 'Herzuma SC' Development Progressing Smoothly

Pursuing Differentiated SC CMO Business

Celltrion announced on December 8 that it will expand its new pipeline by internalizing subcutaneous (SC) formulation technology based on hyaluronidase, which enables the conversion to SC formulations. Starting from this point, the company plans to apply SC conversion technology to a wider range of biosimilar products and new drug pipelines in the future.

The hyaluronidase-based SC formulation technology internalized by Celltrion temporarily breaks down hyaluronic acid (HA), which exists in subcutaneous tissue, to facilitate drug diffusion. By decomposing HA, the tissue space at the injection site expands and absorption increases, and the decomposed HA naturally regenerates over time, making safety concerns relatively minimal. Leveraging these properties, it is possible to develop relatively high-concentration and high-dose products in SC form.

Celltrion has been conducting approval clinical trials for Herzuma SC (development code CT-P6 SC), which utilizes this technology, since February this year. The company recently completed patient dosing and plans to submit an application for additional approval of the Herzuma SC formulation to domestic and international regulatory agencies in the first half of next year. While the existing intravenous (IV) formulation required about 90 minutes for administration (30 minutes for maintenance therapy), switching to the SC formulation can reduce the administration time to within approximately 5 minutes.

Herzuma, an anti-cancer antibody biosimilar, currently holds a 75% market share in Japan, ranking first, and has expanded to a 32% market share in Europe, demonstrating leading sales performance in major global markets. Celltrion expects that by adding the SC formulation of Herzuma, it will secure a full product lineup with both IV and SC options, further accelerating market expansion based on this foundation.

Furthermore, as global interest in SC conversion technology continues to rise, Celltrion has now internalized hyaluronidase-based SC formulation technology in addition to its experience in commercializing the world’s first infliximab SC (Remsima SC, marketed in the US as Zymfentra) in global markets. This means the company now possesses comprehensive capabilities for customized SC development.

Through this, Celltrion has established itself as the only domestic company with a full value chain that covers the entire process from SC formulation productization, approval, mass production, to global supply. This structural differentiation provides Celltrion with a unique and unrivaled competitive advantage compared to companies that possess only a single technology.

Based on its customized SC formulation development capabilities, Celltrion also plans to pursue contract manufacturing organization (CMO) business for formulation changes of externally commissioned products. The company believes it can provide one-stop services across the entire SC conversion process, backed by its customized SC conversion technology, global commercial production infrastructure, and experience with major regulatory approvals. Such services are highly promising, as they can be applied not only to biosimilars but also to high-dose biologics such as anticancer drugs and autoimmune disease treatments.

Going forward, the company plans to implement a step-by-step SC technology-based growth strategy focused on three pillars: SC conversion of its biosimilar product lineup, SC application to new drug pipelines, and expansion of formulation change CMO business for external clients.

A Celltrion official stated, “SC conversion technology is an area of high interest for global pharmaceutical companies because it enhances patient convenience and improves hospital operational efficiency, but there are not many companies with integrated capabilities across the entire process. Once the development of Herzuma SC is completed, we will be equipped not only to enhance product competitiveness but also to provide SC formulation conversion services to external clients.”

This content was produced with the assistance of AI translation services.